AMPLIFY-EXT (Version 1, 20 Jun 08)

• Research type

  Research Study

• Full title

  A Safety And Efficacy Trial Evaluating The Use Of Apixaban For The Extended Treatment Of Deep Vein Thrombosis And Pulmonary Embolism

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2007-004953-27

• ISRCTN Number

  n/a

• Research summary

  The study was developed by Pfizer and bristol-Myers Squibb to provide an effective and safe treatment to prevent late recurrences of deep vein thrombosis (DVT) and pulmonary embolism (PE), as there is a 3% risk of recurrence per year for 10 years.patients with DVT/PE, which is confirmed by imaging, and who have been taking anticoagulant treatment for 6-12 months will be asked to participate in the trial and commence apixaban treatment.patients will receive either 2.5 mg apixaban, 5mg apixaban or placebo apixaban to allow us to determine which dose provides the optimum balance of safety and efficacy for extended treatment of DVT/PE.patients will receive drug for 12 months and will attend hospital on 8 occasions to follow up on any side effects they have had. patients will also be asked to make an emergency visit to the hospital if they develop symptoms of DVT, PE orisignificant bleeding.In this case, the patient will undergo a diagnostic examination to confirm recurrence of DVT/PE.The study is taking place in approximately 35 countries and 2430 patients are expected to be recruited, with 80-100 of them in the UK.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  08/H0405/44

• Date of REC Opinion

  16 Dec 2008

• REC opinion

  Further Information Favourable Opinion